U.S. FDA panel to advise on whether — and how — Covid vaccines should be updated

FDA panel to advise on whether — and how — Covid vaccines should be updated The FDA faces an important decision in coming days — whether to instruct companies that make Covid-19 vaccines to update the viral strain or strains of SARS-CoV-2 those products target. Helen Branswell STAT

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It seems almost a given that the FDA will tell manufacturers that it is time to change the composition of Covid vaccines, with an eye to a rollout of updated vaccines to be administered in the autumn. But how and to what are questions that still need answering.

The agency is seeking the advice of its independent panel of vaccine experts, the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, to help it decide how, in the words of senior FDA official Peter Marks, to predict the future. VRBPAC meets Tuesday to discuss the issue.

“This is actually one of the more challenging scientific and scientifically nuanced decisions that FDA has to make because, in a sense, we are trying to predict the future based on probability and odds and the best scientific data that we have, knowing full well that this virus has surprised us previously,” Marks, director of FDA’s Center for Biologics Evaluation and Research, told STAT in an interview late last week.  ...